The Federal Court (Justice O’Reilly) issued decisions May 27 in two similar cases (Sandoz 2014 FC 501 and Ratiopharm 2014 FC 502) and concluded that generics firms that market generic products (even under a licencing agreement from the patent holder) are not patentees for purposes of PMPRB price regulation so long as there is no monopoly (market exclusivity).
From the Sandoz decision:
“In my view, the mere fact that a subsidiary generic company sells a version of a patented medicine is insufficient to bring it within the definition of a patentee.”
“ On the other hand, in those cases where a generic company owns a patent and holds a monopoly for a drug, that company could be a “patentee” and come within the Board’s jurisdiction.”
“While the Board began by correctly identifying the purpose of the legislation and the leading cases on the issue (ICN Pharmaceuticals, Inc and Celgene), in my view, it placed too much emphasis on the “consumer protection purpose” of the legislation. That purpose is served solely by reviewing the prices at which patent holders sell patented medicines to determine whether, by virtue of their monopolies, those prices are too high. The legislation is not aimed at protecting consumers from high drug prices generally, and the Board’s role certainly does not extend that far.”
The decision may be appealed by the Attorney General on behalf of the PMPRB.